FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENT, FIREFLY #395
K Number: K781807
·
Decision Nov 22, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
37
Applicant Total
16
Review Days
28
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Basic Information
- Device Name
- REAGENT, FIREFLY #395
- K Number
- K781807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Chrono-Log Corp.
- Date Received
- October 25, 1978
- Decision Date
- November 22, 1978
- Product Code
- JOZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | FDA class 2 | Hematology |
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Other Clearances by Chrono-Log Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | Dec 2, 2016 | Substantially Equivalent |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Oct 14, 2005 | Substantially Equivalent |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Apr 2, 2004 | Substantially Equivalent |
| K962426 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | Oct 22, 1996 | Substantially Equivalent |
| K945414 | RISTOCETIN COFACTOR ASSAY KIT | Jan 11, 1995 | Substantially Equivalent |
| K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | Oct 13, 1994 | Substantially Equivalent |
| K932566 | AGGRO/LINK CONTROL SOFTWARE | Nov 2, 1993 | Substantially Equivalent |
| K922800 | PLATELET AGGREGATION REAGENTS | Aug 26, 1992 | Substantially Equivalent |
| K851025 | AGGRO/LINK COMPUTER INTERFACE | Jun 12, 1985 | Substantially Equivalent |
| K850592 | PLATELET AGGREGATION REAGENT | May 13, 1985 | Substantially Equivalent |